MAUDE Adverse Event Reporting--Cosmetic Devices

MAUDE - Manufacturer and User Facility Device Experience. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Also, warning letters issued to device makers for FDA violations.

MAUDE Adverse Event Reporting--Cosmetic Devices

PostPosted by DCNGA » Wed Aug 11, 2010 4:31 pm

I simply went to the MAUDE (FDA) Adverse Reaction Database and did a a search of "powered, laser". I've copied in only some, certainly not all. Those from laser surgeries, non-cosmetic are part of the total 1,473 adverse reactions in the last couple of years. Those included in this post are for cosmetic medical devices.

The MAUDE database can be searched at this link:

http://www.accessdata.fda.gov/scripts/c ... search.cfm

SOLTA MEDICAL, INC. FRAXEL LASER

Model Number CANNOT FIND IN FILE
Event Date 03/08/2008
Event Type Injury Patient Outcome Disability;
Event Description
I had six sessions of fraxel at the (b) (6) skin institute in (b) (6) for acne scarring. Over the time of treatment, i saw very little if any improvement to my skin. There was no change to my scars, but they said it will come with time. The last session, the nurse who performed the treatment asked if i wanted her to do an extra laser pass. I said ok, confident that this product and professional would not damage the skin on my face. That night my skin reacted very differently than it did previous times. I had major swelling and loads of clear liquid came out of my skin. My pillow was covered and when i woke, my skin was totally crusted over and i rinsed it off. Over the next few days, i developed scabs on my face that i am sure contributed to new scars forming on my face. Over the next few weeks, i noticed new scars on my face. My face continually had a tingling sensation. I went back to the doctor's office and they did not have any idea how this happened to me. They almost dismissed my concern and did not listen when i showed them specific scars that were new. It has been two years since this horrible experience, and it is still affecting my life. I never fathomed that this could ever, ever happen from doing the fraxel laser. I only wanted some kind of improvement and when i got was more scars. This is my face and i have no idea what will happen in the future. I have visited about five dermatologists and no one has an explanation. I have lost confidence and happiness because of this experience. One year ago, dr. (b) (6) asked that i come in for a follow up and he again had no explanation and said i can always do punch grafts to fix the damage? i would never go back to his office again. He also offered me my money back as long as i signed a waiver. In his notes he mentions that my mother accused him of treating me like a guinea pig and he gave me my money back because i was so accusatory? i was only explaining what happened to my face after my last fraxel, new scars and holes! he says he pointed out each scar in a before picture, that is false because they don't even have a before picture for one side of my face. Dates of use: (b) (6) 2007 to (b) (6) 2008. Diagnosis or reason for use: acne scarring.
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Re: MAUDE Adverse Reaction Filings

PostPosted by DCNGA » Wed Aug 11, 2010 4:34 pm

Model Number MC-SYS-SR1500-D-US
Event Date 11/17/2009
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
The treatment tip was not returned for eval. No further information is available about this event.


Event Description
On (b) (6) 2009, solta was notified of an event where a pt had received burns to the tops of her hands during a fraxel treatment after a treatment on (b) (6) 2009. The treatment settings were 10mj at 40% coverage. No errors were reported during treatment and the treatment tip was discarded after treatment. On (b) (6) 2009, a follow-up call was made. The pt stated that she was taking antibiotics (keflex) and keeping her hands dry. The pt reported that her hands were healing. On (b) (6) 2009, the pt reported that her hands were healing and had no open lesions, but left hand was still slightly swollen and discolored, and her right hand was back to normal with only a few discolored areas. She used silvadene ointment for a few days to help with healing and had just finished her course of oral antibiotics (keflex). Pt relayed that she would email photos, however, no photos were received from the pt. On (b) (6) 2010, follow-up, the pt stated that she had residual scarring and discoloration to both hands. Date of reportability determined on 3/29/2010, upon confirmation of scarring to tops of hands.
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Re: MAUDE Adverse Reaction Filings

PostPosted by DCNGA » Wed Aug 11, 2010 4:40 pm

Brand Name VASCULIGHT HR
Type of Device INTENSE PULSE LIGHT DEVICE
Manufacturer (Section F) LUMENIS LTD. YOKNEAM
13 hayetzira st
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer (Section D) LUMENIS LTD. YOKNEAM
13 hayetzira st
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer (Section G) LUMENIS LTD. YOKNEAM
13 hayetzira st
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer Contact annie hung
5302 betsy ross drive
santa clara , CA 95054
(877) 586 -3647

Device Event Key 1807197
MDR Report Key 1767551
Event Key 1676804
Report Number 2914019-2010-00036
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/21/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 07/21/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number GA2400000
Device Catalogue Number GA2400000
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer 06/28/2010
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 06/22/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 03/01/2001
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse
"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings

PostPosted by DCNGA » Wed Aug 11, 2010 4:42 pm

PALOMAR MEDICAL TECH PALOMAR STARLUX 500 IPL

Lot Number 1111
Event Date 06/09/2009
Event Type Injury Patient Outcome Required Intervention; Other
Event Description
Burned by ipl skin rejuvenation procedure, palomar sarlux 500, by (b)(6) under the supervision of (b)(6) at (b)(6). Rec'd 2nd degree burns and blisters to chest and burns to entire face. Esthetician used settings outside of palomars range considered very high for skin type. One year later, still have permanent scars, vision problems, facial atrophy, throat and swallowing problems, digestion and bowl problems, skin rash and unexplained muscle loss and sever illness after 59 doctor appointments and still no diagnosis. Dates of use: (b)(6) 2009 - (b)(6) 2009. Diagnosis or reason for use: cosmetic.

Brand Name PALOMAR STARLUX 500
Type of Device IPL
Manufacturer (Section F) PALOMAR MEDICAL TECH
burlington MA

Manufacturer (Section D) PALOMAR MEDICAL TECH
burlington MA

Device Event Key 1805648
MDR Report Key 1766886
Event Key 1676190
Report Number MW5016781
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/16/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 07/16/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other
Device LOT Number 1111
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?



---
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Re: MAUDE Adverse Reaction Filings

PostPosted by DCNGA » Wed Aug 11, 2010 4:44 pm

LUMENIS LTD. YOKNEAM LUMENIS ONE INTENSE PULSE LIGHT DELIVERY DEVICE

Model Number IPL
Event Date 06/08/2010
Event Type Injury Patient Outcome Other;
Brand Name LUMENIS ONE
Type of Device INTENSE PULSE LIGHT DELIVERY DEVICE
Manufacturer (Section F) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam

Manufacturer (Section D) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam

Manufacturer (Section G) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam

Manufacturer Contact steve kachocki
5302 betsy ross rd.
santa clara , CA 95054
(877) 586 -3647

Device Event Key 1798511
MDR Report Key 1760673
Event Key 1670322
Report Number 2914019-2010-00035
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/14/2010
1 Device Was Involved in the Event
2 PatientS WERE Involved in the Event: 1 2
Date FDA Received 07/14/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number IPL
Device Catalogue Number GAL140000
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer 07/06/2010
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 06/14/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 07/01/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse
"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 4:48 pm

Model Number ENCORE
Event Date 10/14/2009
Event Type Injury Patient Outcome Disability;
Brand Name ULTRAPULSE ENCORE AESTHETIC PACKAGE
Type of Device CARBON DIOXIDE SURGICAL LASER DELIVERY DEVICE
Manufacturer (Section F) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam

Manufacturer (Section D) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam

Manufacturer (Section G) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam

Manufacturer Contact steve kachocki
5302 betsy ross rd.
santa clara , CA 95054
(877) 586 -3647

Device Event Key 1798515
MDR Report Key 1760674
Event Key 1670323
Report Number 2914019-2010-00029
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/14/2010
1 Device Was Involved in the Event
2 PatientS WERE Involved in the Event: 1 2
Date FDA Received 07/14/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number ENCORE
Device Catalogue Number GA-0000030
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer 06/30/2010
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 06/22/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 03/01/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse
"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 4:51 pm

Model Number TITAN XL
Event Date 03/05/2010
Event Type Injury
Event Description
Event: "pt received burn. Pt didn't perform burn care, burn got infected. Antibiotics prescribed, area healed, scarred. Product problem: end block corrosion. Dose or amount: 31-33j/cm2. Frequency: per pulse. Route: transdermal. Dates of use: (b) (6) 2006 - (b) (6) 2010. Diagnosis or reason for use: unk.

Brand Name TITAN XL
Type of Device TITAN
Manufacturer (Section F) CUTERA
brisbane CA

Manufacturer (Section D) CUTERA
brisbane CA

Device Event Key 1772077
MDR Report Key 1729507
Event Key 1641547
Report Number MW5016398
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/15/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 06/15/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number TITAN XL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer 05/18/2010
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 06/15/2010 Patient Sequence Number: 1
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 4:53 pm

Model Number TITAN XL
Event Date 05/14/2010
Event Type Injury
Event Description
Event: "burns and blisters". Product problem: end block gold coating failure. Dose or amount: 32j/cm2 to 38j/cm2, frequency: per pulse, route: transdermal. Dates of use: (b) (6) 2006 - (b) (6) 2010. Diagnosis or reason for use: unk. Event abated after use : no.
Brand Name TITAN XL
Type of Device TITAN
Manufacturer (Section F) CUTERA
brisbane CA

Manufacturer (Section D) CUTERA
brisbane CA

Device Event Key 1768460
MDR Report Key 1724932
Event Key 1637373
Report Number MW5016334
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/10/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 06/10/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number TITAN XL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer 06/09/2010
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 06/10/2010 Patient Sequence Number: 1
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 4:54 pm

Model Number TITAN XL
Event Date 12/31/2009
Event Type Injury
Event Description
Event: burns and blisters; pt had titan treatment 1 year prior at same settings. Product problem: gold coating on end blocks failed. Dose or amount: 34j/cm2; frequency: per pulse; route: transdermal. Dates of use: (b) (6) 2007 - (b) (6) 2010. Diagnosis or reason for use: unk. Event abated after use: yes.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 4:55 pm

Model Number XL
Event Date 05/04/2010
Event Type Injury Patient Outcome Other;
Event Description
On (b) (6) 2010, titan handpiece evaluated for preventive maintenance. Output energy measured within cutera specification. On (b) (6) 2010 event, the client received a titan treatment in (b) (6) 2010 with "no problems, tolerated well". The same client received a titan treatment (b) (6) 2010 at same settings used in (b) (6) 2010 treatment and "she complained that it was too hot and the client said that it left a blister on her skin". On (b) (6) 2010, titan handpiece evaluated; product problem: 1- partial connection of the anode lead 2- end block corrosion. Dose or amount: 38j/cm2 frequency: per pulse. Route: transdermal. Dates of use: 1 treatment, (b) (6) 2010 -- (b) (6) 2010.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 4:56 pm

Event Date 03/29/2010
Event Type Injury
Event Description
Event: treatment provider stated: "while treating the right side of the face, forehead and chin the discomfort produced was disproportionately high". "there were subsequently two areas of blistering. One on the left chin, which subsequently healed and one on the central forehead, which granulated slowly but with some scarring". Product problem: end blocks gold coating had failed. Dose or amount: 36-40 j/cm2, frequency: per pulse. Route: transdermal. Dates of use: 1 treatment (b) (6) 2010 -- (b) (6) 2010.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 4:57 pm

Model Number LIGHTSHEER ET
Event Date 04/29/2010
Event Type Injury
Manufacturer Narrative
Reasonable attempts were made to obtain additional information from the user facility, however, none was provided. A review of service records for the user facility concluded that no service had been performed by lumenis since 04/05/2005. A review of the reported event details concluded that insufficient information was provided to determine a root cause. Should additional information be reported a follow up mdr will be filed.


Event Description
It was reported that a patient sustained scarring after hair removal treatment with a lightsheer et laser.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 4:59 pm

Fraxel Re Pair
Event Date 03/02/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
I had fractional co2 skin resurfacing on the above date. I believe it was fraxel repair since i was told that it needed to be done only once and that it would last 5 to 7 years. -cost 7k- since that time, the dr has tried to work with me to make my problems go away -by doing additional fraxel- he said that it should work but it has only made things worse. However, as of this date (b) (6) 2010, i still have large brown spots covering both cheeks, large pores and regular break outs of small white bumps around the eye area. In addition, on the chin, around the eyes and sides of mouth it looks like someone took a fork and created lines that were not there before and rough skin all over. I have a picture of myself taken the day i went in for my consultation and would be glad to have one taken now if needed for your files. These are skin conditions that i never had before, and i look much worse than before my fraxel treatments. I believe this machine should not be used on any other patient. I know of two other individuals who went to the same dr and have had similar problems. Dates of use: (b) (6) 2009 - (b) (6) 2010. Diagnosis or reason for use: make skin look better and smooth. Event reappeared after reintroduction: yes.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:04 pm

THREE PATIENTS BURNED/ONE REPORT

LUMENIS LTD. YOKNEAM ULTRAPULSE ENCORE AESTHETIC PACKAGE CARBON DIOXIDE SURGICAL LASER Back to Search Results

Model Number ENCORE
Event Date 03/24/2010
Event Type Injury
Manufacturer Narrative
An examination of the subject device by a lumenis technical specialist confirmed that there was no related device malfunction and the device performed within acceptable performance specifications. Reasonable attempts were made to contact the user facility for additional information, however, none was provided. Should additional information be reported, a follow up mdr will be filed.


Event Description
It was reported that three patients sustained facial scarring after rhytid treatment with an ultrapulse encore laser.
Brand Name ULTRAPULSE ENCORE AESTHETIC PACKAGE
Type of Device CARBON DIOXIDE SURGICAL LASER
Manufacturer (Section F) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam IL 20692

Manufacturer (Section D) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam IL 20692

Manufacturer (Section G) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam IL 20692

Manufacturer Contact annie hung
5302 betsy ross drive
santa clara , CA 95054
(877) 586 -3647

Device Event Key 1709040
MDR Report Key 1666548
Event Key 1583534
Report Number 2914019-2010-00018
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/22/2010
1 Device Was Involved in the Event
3 PatientS WERE Involved in the Event: 1 2 3
Date FDA Received 04/22/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number ENCORE
Device Catalogue Number GA-0000530
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer 04/13/2010
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 03/24/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 08/01/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/22/2010 Patient Sequence Number: 3
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:05 pm

SOLTA MEDICAL FRAXEL REPAIR ELECTROSURGICAL UNIT AND ACCESSORIES Back to Search Results

Model Number MC-SYS-RE-PAIR-US
Event Date 03/19/2010
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
The treatment tip was not returned for evaluation. No further information is available about this event.


Event Description
On (b) (6) 2010, solta was notified of a patient that had scarring on the neck following a fraxel repair treatment. The physician did not remember the treatment settings or the exact date the patient was treated. Pictures of patient show scarring to the neck approximately one year after treatment were received on (b) (6) 2010.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:06 pm

LUMENIS LTD. YOKNEAM ULTRAPULSE ENCORE AESTHETIC PACKAGE CARBON DIOXIDE SURGICAL LASER Back to Search Results

Model Number ENCORE
Event Date 07/22/2009
Event Type Injury
Manufacturer Narrative
An examination of the subject device by a lumenis technical specialist concluded that the device operated to mfg specifications. No related device malfunctions were reported or observed. A review of product labeling concluded the probable root cause of the reported events to be failure to perform a test patch on the pt prior to treatment in contradiction to product labeling.

Event Description
It was reported that a pt sustained hypertrophic scarring and hypopigmentation in the perioral area after treatment for perioral rhytids with an ultrapulse encore laser
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:07 pm

SOLTA MEDICAL FRAXEL RE:PAIR ELECTROSURGICAL UNIT AND ACCESSORIES Back to Search Results

Model Number MC-SYS-RE:PAIR-US
Event Date 10/27/2009
Event Type Injury Patient Outcome Other;
Event Description
On (b) (6) 2009, solta was notified of an event where a pt had developed an infection following a fraxel re:pair treatment. Pt took valtrex and levaquin for 7 days before treatment on the forehead, nose, cheeks, neck and chest. Erythema was noted on the pt's face during treatment. The pt was seen the day after treatment and showed normal wound healing. Pt returned to physician's office on (b) (6) 2009 with severe itching and papular dermatitis on the chest and neck. On (b) (6) 2009, pt was seen and displayed new papular lesions on face, and pustules on the neck and chest. She had a temp of 100. 8 and a headache and md assumed it was a viral infection. Pt was admitted to unc hosp on unk date and started on iv antibiotics and vancomycin. Biopsies were taken with no unusual results. Bacterial cultures negative. Viral culture was pending at that time. On (b) (6) 2010, dr (b) (6) confirmed that pt test positive for mycobacterium, however, specific strain was undetermined. Pt was reported to have scarring to neck region.


Manufacturer Narrative
The treatment tip was not returned for eval. The (b) (4) health dept performed swabs of the clinic as well as the pt's house for bacteria. Results inconclusive.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:08 pm

SOLTA MEDICAL FRAXEL RE:PAIR ELECTROSURGICAL UNIT AND ACCESSORIES Back to Search Results

Model Number MC-SYS-RE-PAIR-US
Event Date 02/23/2010
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
The treatment tip was not returned for eval. Swabs taken of affected skin and punch biopsy inconclusive for mycobacterium.


Event Description
On 02/23/2010, solta was notified of an event where a pt developed an infection following a fraxel re: pair system. The pt was treated on the neck on (b) (6) 2009. The pt returned to the physician's office on (b) (6) 2010 and pustules were noticed under the right side of her chin. A bacterial swab was performed and the pt was restarted on keflex and valtrex, and given topical altabax. Pt returned on (b) (6) 2010 with new lesions. A tissue swab and 2 mm punch biopsy was performed, which preliminarily grew group b strep, so the pt was switched to penvk. Pt also given diflucan for possible yeast infection. Pt photos received on 3/19/2010 indicated possible hypertrophic scarring on neck.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:29 pm

AMLA Laser ACCENT
Event Date 03/01/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
Pt underwent a treatment with the alma laser manufactured accent ultra rf device for a facial rejuvenation procedure. The pt received a third degree burn resulting in a large ulcer on her face requiring immediate and continuous medical intervention with a prognosis of a permanent disfiguring scar. Dates of use: (b) (6) 2010 - (b) (6) 2010. Diagnosis or reason for use: facial skin tightening. Event abated after use stopped or dose reduced? no.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:29 pm

LUMENIS, LTD. YOKNEAM ULTRAPULSE ENCORE AESTHETIC PACKAGE CARBON DIOXIDE SURGICAL LASER
Model Number ENCORE
Event Date 08/26/2009
Event Type Injury
Manufacturer Narrative
An examination of the subject device by a lumenis technical specialist concluded that the device operated to manufacture specifications. No related device malfunctions were reported or observed. A review of product labeling concluded the probable root cause of the reported events to be failure to perform a test patch on the pt prior to treatment in contradiction to product labeling.

Event Description
It was reported that four pts sustained hypertrophic scarring and hypopigmentation in the perioral area after treatment for deep rhytids with an ultrapulse encore laser. It was further reported that three of the pts were treated with cordran tape and kenalog injections.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:31 pm

RELIANT TECHNOLOGIES FRAXEL FRAXEL, RESTORE
Event Date 11/18/2009
Event Type Injury Patient Outcome Other;
Event Description
I received a fraxel restore laser treatment and have since had adverse effects. Effects include severe hyperpigmentation and rough skin following treatment. The nurse practitioner had me sign a form, but never talked to me about risks and said no one has ever had issues at her office. Dose or amount: 1 session.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:33 pm

PALOMAR STARLUX PALOMAR STARLUX INTENSE PULSED LIGHT SYSTEM

Event Date 11/20/2007
Event Type Injury Patient Outcome Required Intervention; Other
Event Description
I went to (b) (6) in (b) (6) to have an age spot removed. It was recommended that i receive a photo facial using the palomar starlux intense pulsed light system. I had extremely dry skin under my eyes and facial fat loss in my cheeks. Dose or amount: 1 treatment. Event abated after use stopped or dose reduced?: no.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:34 pm

Fraxel RePair
Event Date 02/13/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
Four treatments with fraxel restore has left full face dark skin, made skin texture worse, seem to have aged five years with extreme lines all over face. 2008, 2009.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:35 pm

RH USA, INC. LIGHTSHEER DUET OTHER: DIODE
Model Number LIGHTSHEER DUET
Event Date 12/03/2009
Event Type Other
Event Description
It was reported that a patient sustained blisters and scabbing to the back of the thigh after hair removal treatment with a lightsheer duet laser. It was further reported that biafine was prescribed.


Manufacturer Narrative
An evaluation of the event details by a lumenis medical subject matter expert concluded that the treatment parameters used by the user facility were within those in the subject device training materials and the common practice for the subject indication. No related device malfunction was reported. Reasonable attempts were made to obtain additional relevant information; however, non was provided by the user facility. Should additional information be received, a follow up mdr will be filed.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:36 pm

LUMENIS LTD. YOKNEAM ULTRAPULSE ENCORE
Model Number ENCORE
Event Date 11/19/2008
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
No pt contact, user facility or subject device identification was provided in the medwatch report. Additionally, no complaint of similar event was reported to lumenis that could be related to this reported event. Therefore, no device eval could be performed. Should more info be provided, a follow-up mdr will be filed.


Event Description
It was reported that a pt sustained scarring of the face after treatment with an ultrapulse laser.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:37 pm

RH USA, INC LIGHTSHEER (ALL MODELS) SOLID STATE AESTHETIC LASER DELIVERY DEVICE: LIGHTSHEER DUET
Model Number DUET
Event Date 10/12/2009
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
An examination and testing of the subject device by a lumenis service subject matter expert concluded that the device operated to manufacture specifications and no related device malfunction was reported or observed. A review of the reported events by a lumenis technical subject matter expert concluded the device performed within specifications. Probable root cause determined to be debris build up on the treatment tip in contradiction to cleaning guidelines in device labeling and training materials.

Event Description
It was reported that three pts sustained hypopigmentation and scarring after hair removal treatment with a lightsheer duet laser system. It was further reported that the pt required no medical intervention.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:38 pm

LUMENIS LTD. YOKNEAM ULTRAPULSE ENCORE AESTHETIC PACKAGE - 120 O.R. CARBONDIOXIDE SURGICAL LASER
Model Number 0642-415-01
Event Date 09/23/2009
Event Type Injury
Manufacturer Narrative
An evaluation of the event details by a lumenis medical subject matter expert concluded that the reported numbers of pulses and passes performed by the user facility were excessive and in contraindication to the treatment parameters recommended by the training materials and the common best practice for the subject indication.


Event Description
It was reported that a pt sustained facial scarring after perioral wrinkle treatment with an ultrapulse encore laser.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:40 pm

LUMENIS LUMENIS TOTAL FX
Event Date 11/19/2008
Event Type Injury
Event Description
A physician treated my face using the lumenis total fx laser. I am now left with laser track marks going across my face, loss of pigment in my upper lip, hyper-pigmentation and permanent scarring on my face. The physician stated "it was the deep fx head of the laser that scarred your face, i should have treated you at a level 2 and done two treatments instead of treating you at a level 4. ".
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:42 pm

LUMENIS LTD. YOKNEAM LUMENIS 1 ND: YAG SURGICAL LASER
Model Number GAL 110000
Event Date 07/14/2009
Event Type Injury
Event Description

It was reported that a pt sustained two small depressed marks to the right side of the nose after telangiectasias treatment with a lumenis one nd: yag laser.


Manufacturer Narrative
An evaluation of the reported treatment settings and case detail by a lumenis medical specialist concluded the probable root cause of the reported event to be post treatment sun exposure in contradiction to product labeling. An on-site examination of the subject device by a lumenis technical expert concluded that the subject device performed within expected performance specifications. No related device malfunction was reported or observed during the service investigation.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:44 pm

IRIDEX GEMINI LASER
Event Date 07/15/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
I had a laser skin resurfacing procedure done on my neck, face, and forehead. The laser was a gemini laser by a company called iridex. Immediately after my face was covered with bright red spots, swelling, burned hair, and burn on face. I had a ipl treatment done 4 weeks prior without any side effects. The same day, i continued to notice severe discoloration, hypo pigmentation, red/burns, etc. The hypo pigmentation and adverse effects on acne scarring is getting worse by the day. I have seen many dermatologists and plastic surgeons since then, and consensus is the settings are too high. I pulled the iridex product brochures and they do not provide sufficient warnings about their products, nor did my dermatologists who switched me from ipl to laser causing irreversible damage to my skin. I have gone on numerous blogs and websites, and there are many clients whom have been permanently damaged by these products. I take responsibility in trying to improve aesthetically my appearance, but there is no ample pre-caution or awareness on lasers. The damage they conduct are permanent physically, emotionally, and mentally. Something needs to be done. Dose: 532 nm, 6 joules, 23 millisecon. Dates of use: 2009. Diagnosis: rosacea/sun damage. Event abated after use stopped: yes.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:54 pm

SOLTA MEDICAL FRAXEL RE: STORE/ RE: FAIR LASER FRACTIONAL LASER
Event Date 02/06/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
Fraxel laser treatment of the face caused the following conditions: i have permanent swelling in the jowl area, hyper-pigmentation, thickened scaly skin and bumps on the nose - rhinophyma, itchy burning rush all over face, red bumps - that look somewhat like pimples or mosquito bites - continually pop up, scarring all over face, bluish discolored spots on skin, stretch marks on skin, and if i go out in the sun for even a minute, i break out in red blisters. The doctor wanted nothing to do with any follow-up care. He felt the negative results were not his responsibility. Dates of use: 2009. Diagnosis or reason for use: acne scars/oiliness.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:56 pm

RELIANT FRAXEL RESTORE
Event Date 07/10/2008
Event Type Injury Patient Outcome Required Intervention; Disability Other
Event Description
The doctor recommended fraxel treatment for melasma per doctor during diagnoses. Requested more info. Given no verbal info about treatment by doctor first intent and brochure. Fraxel ruined my skin made the pigmentation go into my dermis, which made my skin gray and ashy and put lines around my eyes. Went to 3 doctors, stated to me that there is no treatment for dermal pigmentation. Fraxel should be off the market! no lab test by the dermatologist. I had a skin biopsy, which showed heavily pigmented melanophages and spotty chronic inflammatory cell infiltrate, which was mostly concentrated around the follicular units. Also revealed ongoing element of folliculitis is possible. This all came from one fraxel restore treatment. Completely destroyed my skin and my life. This should be removed from the market. Very dangerous device. Totally unpredictable for skin. If you want to see my biopsy report i can mail it. Thanks. Dose: unk. Frequency: unk. Diagnosis: melasma.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:57 pm

CUTERA TITAN LASER/LIGHT DEVICE
Event Date 02/27/2009
Event Type Injury Patient Outcome Disability;
Event Description
Pt underwent treatment with cutera titan laser for face by a nurse. Noted significant pain after a few passes. Treatment was stopped by the treating nurse. She developed severe second and third degree burns on the treated cheek, which then required skin grafting to some and have left permanent hypertrophic erythematous scars -total # = 7 scars-. According to the pt, the treating physician notified the manufacturer, cutera and the device was inspected by the manufacturer. She was seen in our office in 2009 with seven permanent linear erythematous and hypertrophic scars on the cheek. Dates of use: 2009. Diagnosis or reason for use: skin laxity. Event abated after use stopped or dose reduced: yes.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:58 pm

PULSED DYE LASER
Event Date 09/25/2006
Event Type Injury Patient Outcome Required Intervention;
Event Description
In 2006, a dermatologist was treating my rosacea with a pulsed dye laser which burned, scarred, caused nerve damage and fatloss in my face. The laser removed all the detail from my face. I have textural -scars- changes outside and inside my skin, fat loss. I lost the width of my cheeks and jaw line, the padding on the upper part of my cheeks and this changed the structure of my face. I have discoloration and have lost skin elasticity and there were welts under my cheekbones. I have nerve damage around my perioral area. I have hollowed eyes. The laser removed all the water from my skin. My skin i cannot describe. Prior to this treatment, i had good skin. The laser aged my skin. I think the equipment might have malfunctioned or the energy was so high that it created a shockwave under my skin because i could feel the pain like a wave going down my face. Part of my neck is affected. This injury and the doctor abandoning me not able to find anyone to help me has ruined my every day life. Sometimes i don't know how i can cope with all of this. People should be told about these side effects - they are permanent and devastating. According to the dermatologist i was supposed to have three treatments. My first treatment was performed at a much lower energy and i was told that a vbeam was used. I felt no pain and was fine. I am not sure what laser was used during my second treatment because it was extremely painful and did not feel the same as the first. My medical record states that the pulsed dye laser was used for both treatments. However, my second treatment took place in another room so it probably was not the vbeam but another brand of the pulsed dye laser. I am filing this report to let the food and drug administration know that these devices are dangerous even in professional hands and can cause horrific physical and emotional injuries.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 5:59 pm

CANDELA CORP. CANDELA CORP. V BEAM LASER NONE
Event Date 01/19/2005
Event Type Injury Patient Outcome Disability; Other
Event Description
In early 2005, i went to see a dr. I would like to notate that this was only to be a consultation for a preventative measure, as i am an actress and i wanted to maintain my good skin condition. However, dr turned this into a money making opportunity and sold me on using the candela laser "v beam" and "smooth beam" lasers at that consultation. He told me it is a "lunchtime" procedure and would not damage or injure my skin at all. This was a lie. Further, he ignored the fda, and used both of these lasers at the same sitting, when they were not approved to be used together. They are to be used separately on separate appointments. However, dr never bothered to mention this fact to me when he overbearingly told me that they 'both had to be used together', when i objected to having anything done on my beautiful skin on my cheeks. Dr insisted on using both the v beam and the smooth beam together. This is in direct violation of fda approval. The results were a disaster. I had severe bruising, swelling hyper-pigmentation, and redness, like i had been cooked like a tomato. I was in severe pain, like i had been burnt. The doctor rushed out of the room and said nothing. When i called him a few days later to complain via phone, since my face was hurting and i could not work - he went into a copy denial. No follow up procedures or instructions were given. I was only given a bill to pay at the front desk and had to walk out of the office looking like i had been mugged and beaten. I was totally embarrassed, but more importantly very concerned about my physical state. This laser procedure seriously injured my skin. I am still healing, four years later, from this one time event that caused me injury. I would like both this doctor [who has violated your guidelines for the usage of these lasers], as well as the candela corporation to be investigated. These are dangerous lasers. Dates of use: one time only, 2005. Event abated after use stopped or dose reduced?: no. Candela corp. , v beam and smooth beam laser early 2005, one time used improperly by a dr.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:22 pm

Model Number FRAXEL REPAIR LASER
Event Date 05/09/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
As reported, i had the fraxel repair laser. I ended up with hypo pigmentation, scars and textural irregularities on the cheeks - it has been well over a year since my treatment. Solta, formerly reliant, manufacturer of the fraxel laser, did file a report with the fda, however, it says praxel laser -twice, 2 typos-. And states i had no hypo pig or scarring. This is not true. I have been asking them to change their advertising for "no risk for hypopigmentation" because of my case, so i am surprised they filed my case as no hypo pigmentation. My laser settings were within the normal range, the fraxel rep was there and had just calibrated the machine, and was present during the entire laser procedure. Blood work and a biopsy showed no virus of anything abnormal. I am extremely fit and healthy. I followed the soaks and all directions to a tee. No one knows what happened. Dose: 20-40 mj. Frequency: once. Dates of use: 2008. Diagnosis: tighter facial skin.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:23 pm

CYNOSURE, INC. CYNOSURE VSTAR
Event Date 02/04/2009
Event Type Malfunction Patient Outcome Other;
Event Description
Pt developed keloid scarring on neck following her 2nd laser treatment with the cynosure vstar. She was treated with the cynosure vstar. She was treated once previously in 2008, with no complications. The same settings -6. 1 j/cm2 in 2009, and 6. 0 j/cm2 in 2008-, cooling, technique and post-treatment skin care used for the 2008 treatment were used for the 2009 treatment. Have been unable to determine a clinical or procedural explanation for the different outcome of the 2nd treatment. Other pts were treated the same day, with the same laser with good outcome. Concerned that there may be an intermittent problem with the laser causing it to randomly fire more intensely despite no change in settings.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:25 pm

Geez....

CUTERA, INC. CUTERA, 2790 NM WAVE LENGTH LASER, CUTERA INC
Event Date 03/06/2009
Event Type Injury Patient Outcome Disability; Other
Event Description
This laser was used on a consultation office visit. I was drugged by the physician and the doctor used the laser all over my face hands, feet, legs joints and sexually abused me with it. I have scarring on my face permanent damage, on my ankles, and possible permanent damage to my face, even used it on my head. The scars are very painful, my skin is wavy and my ankles and legs are skinny vaporized. They look and feel bad. Dates of use: 2009. Event reappeared after reintroduction: yes.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:27 pm

RELIANT TECHNOLOGIES, INC. FRAXEL RE:PAIR LASER SYSTEM NONE
Event Date 05/09/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
Patient experienced delayed wound healing and hyperkeratosis following a single treatment with the fraxel re:pair laser.


Manufacturer Narrative
Patient healed without dermal scarring or hypopigmentation, but still has textural irregularities on both cheeks. No device malfunction was associated with this event.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:33 pm

RELIANT TECHNOLOGIES FRAXEL LASER SKIN RESURFACER
Event Date 03/01/2007
Event Type Injury
Event Description
Hyperpigmentation caused by fraxel laser skin resurfacing: i went to a dermatologist for skin lightening treatment, specifically to eliminate a few dark spots on my face caused by cystic acne. My doctor highly recommended fraxel and was advised that i would need several treatments to achieve best results. I went in for my first -and only- treatment in 2007. We started by taking "before" photos, so we could monitor my progress over the course of the treatments. The procedure went exactly as i had been told. Some mild pain, some redness and swelling on day two and three, followed by some peeling for about a week. I did everything the doctor told me to -- used 50+ sunscreen. Used mild cleansers during the healing phase, didn't scrub my face. Initially i noticed some improvement in my skin's texture but also noticed darkness across my cheeks where previously there had been none. I'm so glad that we had those "before" photos as a reference because when i went in in may for my follow-up visit, the "after" photos confirmed new hyperpigmentation, which my doctor determined was due to the fraxel. Because of my skin's reaction to the first treatment, i decided not to schedule subsequent treatments. My doctor then prescribed a hydroquinone cream, which eliminated my dark acne spots within six weeks. I've continued to use it off and on for over a year on the hyperpigmentation caused by the fraxel laser but it hasn't completely eliminated the hyperpigmentation. Date of use: 2007. Diagnosis or reason for use: dark acne spots. Event abated after use stopped or dose reduced? no.
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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